Category Archives: Medication

celebrex safety label

FDA Advisory Panel Recommends Softening “Celebrex” Safety Labeling

A U.S. Food and Drug Administration (FDA) advisory panel concluded that prescription pain medication celecoxib (Celebrex), marketed by Pfizer, is as safe as other common nonsteroidal anti-inflammatory drugs (NSAIDs) when it comes to cardiovascular (CV) risks. The panel recommended updating the medicine’s safety labeling to reflect that.

Celecoxib is a selective COX-2 inhibitor, which means it blocks production of an enzyme associated with inflammation. “Nonselective” NSAIDs, such as naproxen and ibuprofen, block both COX-1 and COX-2; by blocking COX-1, they give rise to gastrointestinal (GI) side effects. Celecoxib is often prescribed to patients with osteoarthritis (OA) or an inflammatory type of arthritis, such as rheumatoid arthritis (RA), especially those who are at higher risk of GI side effects.

But its cardiovascular safety profile has been under a cloud of suspicion for more than a decade, after two other COX-2 inhibitors were pulled from the U.S. market. Rofecoxib (Vioxx) was removed in 2004 and valdecoxib (Bextra) in 2005 over concerns they raised the risk of cardiovascular events, such as heart attack and stroke, to unacceptable levels. (All NSAIDs increase the risk of cardiovascular side effects; risks rise with the dose and length of time used.)

Celecoxib was allowed to remain on the market; however, the wording on the label was strengthened to say it had increased risk of heart attacks and strokes. The FDA ordered Pfizer to conduct a post-market study of its safety.

That study, called PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen or Naproxen), compared cardiovascular outcomes of prescription doses of celecoxib, naproxen and ibuprofen in more than 24,000 patients with both arthritis and established cardiovascular disease or risk factors. It found rates of cardiovascular side effects were lowest with celecoxib (2.3 percent) compared to naproxen (2.5 percent) or ibuprofen (2.7 percent). (Critics of PRECISION say there were numerous problems with the study, including the facts that more than half of the participants had stopped taking their assigned drug by the end of the study, the allowed doses of the medications were not truly equivalent, and the use of low-dose aspirin, which could throw off the results, was not considered.)

After reviewing results of the study, the FDA Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee voted in a joint meeting in late April, by a vote of 15 to 5 (with one abstention), in favor of updating the safety labeling on Celebrex to reflect this data.

An FDA spokesperson says the matter is pending before the agency, adding that the committee “provided FDA with important perspectives on the topics discussed. FDA cannot speculate about any outcomes from the advisory committee meeting, including the timing of any possible changes.”

The FDA doesn’t have to follow the recommendations of its advisory committees, but it generally does.

A spokesperson for Pfizer, Inc., which had applied for the update, welcomed the vote. “The PRECISION study helped dispel misperceptions about the cardiovascular risk associated with long-term use of Celebrex. In fact, the totality of evidence supports the use of Celebrex to manage pain and inflammation in people with osteoarthritis or rheumatoid arthritis who also have or are at high risk for cardiovascular disease,” said Milton Pressler, MD, vice president and head of clinical affairs for Pfizer.

But Donald Miller, PharmD, professor of pharmacy practice at North Dakota State University, in Fargo, cautions that the dosages in the study may be lower than those that some patients take. The PRECISION trial compared 100 to 200 mg twice a day of celecoxib, 600 to 800 mg three times a day of ibuprofen, and 375 to 500 mg twice a day of naproxen.

“The cardiovascular risk with all NSAIDs is dose-related,” says Miller. “The big issue with the PRECISION study is they only allowed a dose of 200 mg of Celebrex, but it can also be used as a 400 mg dose [200 mg twice daily].”

If you have concerns, discuss your dosage with your doctor, Miller says.

The findings probably will not change how celecoxib is prescribed, he adds, in part because the PRECISION study results were published a year and a half ago.

“From a labeling point of view, this is probably important for Pfizer because it makes the medication less scary,” Miller says. “But rheumatologists are already familiar with this data because the findings of this study were published 18 months ago. So, this decision probably won’t have much effect on practice.”

Author: Jennifer Davis for the Arthritis Foundation

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Two Studies Highlight Opioid Alternatives

The United States has been grappling with a growing opioid epidemic that is forcing doctors, policymakers and patients to come up with alternative ways to manage both chronic and acute pain and reduce the amount of opioid prescribing in the country. A pair of studies presented recently at the 2018 meeting of the American Association of Orthopaedic Surgeons (AAOS) in New Orleans examine two possibilities for patients undergoing surgery.

The first study found that counseling before surgery significantly cuts the number of opioids patients take after hand surgery. And the second study, led by the same doctor, showed that ibuprofen and acetaminophen each treats postsurgical pain from hand surgery as well as oxycodone.

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Synvisc-One Injections Recalled

Biotech giant Sanofi Genzyme has initiated a voluntary product recall for one lot of Synvisc-One, a brand of hyaluronic acid. The lot, which was found to contain contamination, has been linked to an unexpected increase in side effects. In an urgent “product hold” letter, doctors, clinics and pharmacies who received syringes from that lot were instructed to immediately stop using the injections on patients until the company can investigate.
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ibuprofen risk

Ibuprofen May Raise Heart Risk More Than Other NSAIDs

A big study published in 2016, called the PRECISION trial, found that people with arthritis who take the anti-inflammatory drug ibuprofen are more likely to develop cardiovascular problems than those using celecoxib – and now researchers think they know why. Ibuprofen raises blood pressure, according to new findings presented recently at the annual meeting of the European Society of Cardiology in Barcelona.

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fifth arthritis biosimilar

FDA Approves A Fifth Biosimilar for Arthritis, But Three Are Still Not Available

The number of biosimilars approved by the Food and Drug Administration (FDA) continues to grow in the United States, and they are slowly becoming available to consumers.

In late August, the FDA approved Cyltezo (adalimumab-adbm), a second biosimilar to Humira (adalimumab). But like the first biosimilar, Amjevita (adalimumab-atto), which was approved in September 2016, it is not yet available to U.S. consumers because of pending patent litigation with AbbVie, the manufacturer of Humira.

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Top Fibro Treatments

If you’ve been diagnosed with mild to moderate fibromyalgia, exercise and other non-drug therapies should be your first line of treatment, according to the European League Against Rheumatism (EULAR), an international group of health professionals in rheumatology. EULAR’s updated fibromyalgia treatment recommendations, published in 2016 in Annals of the Rheumatic Diseases, are similar to the 2007 version, but this time they are based on hard evidence, which was scarce 10 years ago, rather than on expert opinions.

For the updated guidelines, researchers reviewed 107 research papers. Assessing outcomes for pain, fatigue, sleep and daily functioning, they ranked their recommendations of various therapies as “strong for,” “weak for,” “weak against” and “strong against.”

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